BCI-Controlled Robotic Exoskeleton for Stroke

Not currently recruiting at 1 trial location

Overseen By Lauren Souders, MOT, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurolutions, Inc.

Disqualifiers: Cognitive impairment, Contractures, Receptive aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy for individuals who struggle with arm or hand use after a stroke. It compares a brain-controlled robotic hand device, the IpsiHand Device, with regular at-home exercises. The goal is to determine if the robotic device improves hand and arm movement more effectively than standard exercises. This trial suits those who have experienced a stroke and currently face difficulty moving one arm or hand. As an unphased trial, it provides a unique opportunity to explore innovative technology that could enhance recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are receiving Botox injections for the upper extremity, they must be timed to coincide within a week of the beginning of training.

What prior data suggests that the IpsiHand device is safe for use in stroke patients?

Research shows that the FDA has approved the IpsiHand device, confirming its safety in helping stroke patients regain movement skills. The device uses technology that connects the brain to a computer and has been tested on individuals who experienced a stroke some time ago. These individuals have used it to improve hand movement.

Earlier studies indicate that most people handle the IpsiHand well, with no major safety issues reported. Participants must follow instructions and use the device as directed to prevent any problems.

In simple terms, the IpsiHand device is considered safe for stroke patients, with no major issues found in previous tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stroke rehabilitation methods that focus on physical therapy and exercises, the IpsiHand device is unique because it utilizes a brain-computer interface (BCI) to assist stroke patients in regaining hand movement. This device combines a robotic exoskeleton with EEG technology to interpret brain signals, allowing the exoskeleton to open and close the patient's hand. Researchers are excited about the IpsiHand because it directly engages the brain's neural pathways, potentially leading to more effective rehabilitation outcomes by harnessing the brain's natural ability to reorganize and recover after an injury. This innovative approach could offer new hope for stroke survivors who haven't seen significant improvements with conventional therapies.

What evidence suggests that the IpsiHand device is effective for stroke rehabilitation?

Research shows that the IpsiHand device, which participants in this trial may receive, can help stroke patients improve arm and hand movements. People with long-term stroke effects who used the IpsiHand experienced noticeable improvements, particularly in moving their arms and hands. Studies found that participants made real progress after just three months of using this brain-computer interface (BCI) therapy. The device enhances the brain's interaction with muscles, crucial for stroke recovery. This method offers promising results for those with arm and hand difficulties due to stroke. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who have had a stroke and now experience weakness or paralysis in one arm. They should not be receiving other upper extremity therapies, have severe cognitive impairments, contractures that prevent device use, certain communication difficulties, or conditions affecting pain sensation.

Inclusion Criteria

I have had a stroke.

I am not receiving Botox for my arm, or if I am, it's scheduled around the training start.

I have weakness or paralysis in one arm.

Exclusion Criteria

I can feel pain and do not have nerve or sensory issues that affect this.

You have trouble understanding and following written instructions or have a low score on a language test.

Participants who are pregnant or breast-feeding will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Remote EEG screening

Treatment

Participants receive either the IpsiHand BCI system or a standard home exercise program for 12 weeks

12 weeks

Daily virtual monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IpsiHand Device

Trial Overview The study compares the effectiveness of a home-based brain-computer interface therapy using the IpsiHand System against standard exercises for improving arm function after stroke. Participants will either use the BCI-controlled robotic hand exoskeleton at home or follow an exercise program.

How Is the Trial Designed?

Group I: Standard of Care - Home Exercise Program for Upper Extremity Experimental Treatment 1 Intervention

Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Once randomized, the participant will be assigned to group 2 to begin standard of care treatment at home. Phase 2: After being assigned to Group 2, subjects will serve as the control group in the study. Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks to control for the non-specific motor and sensory effects of BCI training. To help ensure compliance with the at-home portion of the protocol in the control group, participants will receive daily virtual monitoring from the study clinical specialist.

Group II: BCI treatment Group using the IpsiHand Experimental Treatment 1 Intervention

Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Subjects will undergo an EEG screening protocol to ensure that a consistent control signal will be present to control the IpsiHand device. After an EEG screening session is complete, the participants screening data will be analyzed to ensure that sufficient cortical signals are present. Randomization for assignment to group 1 or 2 will then occur. Once assigned to group 1, if consistent signals are found, the participant will then continue to Phase 2. Phase 2: Group 1 subjects will be provided with a Neurolutions IpsiHand BCI system, which combines a novel powered exoskeleton with a commercial EEG amplifier and active electrode system. The exoskeleton opens and closes the patient's hand in a three-finger pinch grip. Patients will use the BCI system on a minimum of 5 days per week for 12 weeks. Patients will complete five or more 10-minute runs of the BCI task per day.

Who Is Running the Clinical Trial?

Neurolutions, Inc.

Lead Sponsor

Trials

4

Recruited

160+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11723815/

IpsiHand Brain–Computer Interface Therapy Induces Broad ... This study investigated the effectiveness of contralesionally-controlled BCI therapy in chronic stroke patients with impaired upper extremity motor function.

2. medrxiv.org medrxiv.org/content/10.1101/2023.08.26.23294320v1

IpsiHand Brain-Computer Interface Therapy Induces Broad ... Results Chronic stroke patients achieved significant motor improvement with BCI therapy. We found significant improvement in both proximal and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02552368

NCT02552368 | Treatment of Chronic Stroke With IpsiHand The second phase of the study will determine if the BCI system can be used to impact rehabilitation. Motor commands would be performed as in phase 1 to ...

4. neurolutions.com neurolutions.com/

Neurolutions | The Latest Breakthrough in Stroke Recovery Participants saw real improvement after just three months of using IpsiHand.

5. anthem.com anthem.com/medpolicies/abcbs/active/mp_pw_e003193.html

DME.00052 Brain Computer Interface Rehabilitation Devices Findings of these studies suggests that the device may improve brain rhythm coordination and motor function in stroke survivors. However, both ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN200046.pdf

driven upper extremity powered exerciser. An EEG-dr The Neurolutions IpsiHand Upper Extremity Rehabilitation System is indicated for use in chronic stroke patients (≥ 6 months post-stroke) age 18 or older ...

7. beonbrand.getbynder.com beonbrand.getbynder.com/m/79ac51bf595f9d14/original/Upper-Extremity-Rehabilitation-System-with-Brain-Computer-Interface.pdf

Upper Extremity Rehabilitation System with Brain- ... The IpsiHand™ is indicated for use in chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re ...